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A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .

NCT00451867 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2010-01-14

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and effectiveness of a medication called CellCept in treating refractory (has not responded to other treatments) interstitial cystitis.

CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants work in the body by reducing the immune system's ability to produce certain reactions that can cause inflammation. In some people, the inflammation produced by their immune system can damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant. When used in combination with other drugs, CellCept helps to prevent the rejection of the transplanted organ and is used widely in patients who have received kidney, liver and heart transplants. CellCept is also frequently used but not FDA approved for the treatment of severe rheumatoid arthritis which is a disease caused when the body's immune system acts against healthy tissues in the joints.

Due to its special activity, CellCept may be useful in treating certain inflammatory diseases or conditions like interstitial cystitis.

Conditions

  • Interstitial Cystitis
  • Painful Bladder Syndrome

Interventions

DRUG

Mycophenolate Mofetil

DRUG

Mycofenolate Mofetil (MMF)

2000 mg per day divided into 2 equal doses.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • John Kusek, PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • LeRoy Nyberg, MD, PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Richard Landis, PhD · University of Pennsylnania

  • David Burks, MD · Henry Ford Hospital

  • Harris Foster, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-02-29
Completion
2008-04-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00451867 on ClinicalTrials.gov